WoundNCT01619137
Soap Versus Normal Salin Plus Povidone-iodine in Ununion Wound
A study testing water and soap and Povidone-iodine And normal salin treatment in people with Wound, run by Aida Najafian at 1 site in Iran.
Trial summary
Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study) Read more about this study
- Who is it for?
- Ages 10 to 60 years, women only
- Conditions the study is for
- Wound
- What is being tested?
- water and soap and Povidone-iodine And normal salin treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Aug 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- all the women coming to Shariati hospital or Gynecologist's office with complain of ununion wound of laparatomy or episiotomy enroll to this study
Who cannot join
- patients not satisfacted to participant in the study exclude of it
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Bandarabbas
Bandarabbas, Hormozgan
Aida Najafian, specialist, +989133090692, dr.aidanajafian@yahoo.com
Aida Najafian, specialist
About this study
Official title: Comparison of the Effect of Water and Soap Irrigation With With Povidone-iodine And Normal Salin Treatment of Patients With Ununion Laparatomy or Episiotomy Wound ( a Pilot Study)
Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study)
Read the detailed description
IN Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study), We use soap in one group and Povidone-iodine And normal salin in other group for irrigation of ununion laparatomy or episiotomy wound.it's require the patients in Povidone-iodine And normal salin group be at hospital till wound be able to closed.
- Conditions
- Wound
- Being tested
- water and soap, Povidone-iodine And normal salin treatment
- Keywords
- ununion wound, soap, irrigation, Povidone-iodine, normal salin
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water and soapDrug
water and soap for 6-8 hours per day.
Povidone-iodine And normal salin treatmentDrug
use of Povidone-iodine And normal salin treatment for irrigation of ununion laparatomy or episiotomy wound.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-iodine And normal salin | Active comparator | 40 patients with complaint of ununion wound of laparatomy or episiotomy coming to Gynecologist's office or hospital enrolled to this study randomly recieve Povidone-iodine And normal salin treatment. Receives: Drug: Povidone-iodine And normal salin treatment |
| water and soap | Active comparator | 40 patients coming to Gynecologist's offices or hospital with complaint of ununion wound of laparatomy or episiotomy in Bandarabbas enrolled to this study and randomly recieve water and soap to irrigation of the wound (it's not require to be at hospital), washing is for each 6-8 hours per day. and if not difference seen after 4 day, treatment change to Povidone-iodine And normal salin. Receives: Drug: water and soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of admission day
number of days the patients in each group admitted in hospital
Measured: 1 month
Secondary outcomes (1)
complication of each treatment
complications include of : infection, reopening of wound, and measurment of opening of wound.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aida Najafian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aida Najafian, Hormozgan University of Medical Sciences
- Investigators
- Aida Najafian, Principal investigator, Hormozgan University of Medical Science (HUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619137
- Sponsor's protocol ID
- soap in ununion wound
- Status last verified
- Oct 2012
- First submitted
- 19 Jan 2012
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Water and Soap Irrigation With With Povidone-iodine And Normal Salin Treatment of Patients With Ununion Laparatomy or Episiotomy Wound ( a Pilot Study)
- ClinicalTrials.gov ID
- NCT01619137
- Acronym / sponsor ID
- soap in ununion wound
- Conditions
- Wound
- Keywords
- ununion wound, soap, irrigation, Povidone-iodine, normal salin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aida NajafianUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study)
Detailed description
IN Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study), We use soap in one group and Povidone-iodine And normal salin in other group for irrigation of ununion laparatomy or episiotomy wound.it's require the patients in Povidone-iodine And normal salin group be at hospital till wound be able to closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone-iodine And normal salin | Active comparator | Drug: Povidone-iodine And normal salin treatment40 patients with complaint of ununion wound of laparatomy or episiotomy coming to Gynecologist's office or hospital enrolled to this study randomly recieve Povidone-iodine And normal salin treatment. |
| water and soap | Active comparator | Drug: water and soap40 patients coming to Gynecologist's offices or hospital with complaint of ununion wound of laparatomy or episiotomy in Bandarabbas enrolled to this study and randomly recieve water and soap to irrigation of the wound (it's not require to be at hospital), washing is for each 6-8 hours per day. and if not difference seen after 4 day, treatment change to Povidone-iodine And normal salin. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all the women coming to Shariati hospital or Gynecologist's office with complain of ununion wound of laparatomy or episiotomy enroll to this study
Key exclusion criteria (1 listed)
- patients not satisfacted to participant in the study exclude of it
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water and soapwater and soap for 6-8 hours per day. | Drug | water and soap |
| Povidone-iodine And normal salin treatmentuse of Povidone-iodine And normal salin treatment for irrigation of ununion laparatomy or episiotomy wound. | Drug | Povidone-iodine And normal salin |
Primary outcome
number of admission day
Time frame: 1 month
number of days the patients in each group admitted in hospital
1 secondary outcome
complication of each treatment
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aida Najafian principal investigator
Hormozgan University of Medical Science (HUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water and soap and Povidone-iodine And normal salin treatment in people with Wound, run by Aida Najafian at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aida Najafian, Specialist (+989133090692, dr.aidanajafian@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of admission day (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2012.